Why the National Academies Got it Wrong about Changing Preemptive Listing Priority for Kidney Transplantation
Authors: Jesse D. Schold, Anne M. Huml, S. Ali Husain, Sumit Mohan
Journal: Journal of the American Society of Nephrology (2023)

In 2022, the National Academies of Sciences, Engineering, and Medicine (NASEM) issued a report entitled "Realizing the Promise of Equity in the Organ Transplantation System," which addressed challenges of organ transplantation in the United States. The report cited copious evidence of systemic inefficiencies and inequities stating that a "shift is needed toward policies that engender accountability to all patients in need of transplant, whether they are on the waiting list yet or not."1 Recommendation 5 from the report was to eliminate predialysis waiting time allocation priority points that currently accrue for patients with advanced CKD who are preemptively placed on the deceased donor waiting list for kidney transplantation. In this perspective, we present a viewpoint that describes serious deficiencies of this recommendation despite the admirable intent to attenuate inequities in care delivery. Currently, waitlisted patients with an eGFR ≤20 ml/min per 1.73 m2 accrue allocation points toward a deceased donor transplant. However, there have been significant racial/ethnic disparities associated with the rates of preemptive waitlist placement, providing the basis for the recommendation in the NASEM report. The current policy of initiating priority for transplantation at the time of advanced CKD is based on numerous potential benefits for patients who extend beyond access to transplantation (Table 1). In fact, there have been extensive efforts over the past decades to improve early identification and care for patients at risk of ESKD on the basis of the health and economic benefits. The benefits of timely and adequate predialysis care include delayed need for renal replacement therapy, reduced complication rates, and lower mortality even in the absence of a transplant. In fact, one of the only instances for Medicare reimbursed education efforts is focused on providing kidney disease and modality counseling, including transplant education, for patients with advanced CKD. This modality counseling allows for timely planning for renal replacement therapy (e.g., fistula placement and home dialysis training) or transplantation (identifying living donors or working toward waitlisting)—all of which lead to better outcomes and lower health care expenditures. Importantly, effective early transplant education has been shown to attenuate racial disparities in care without sacrificing the benefits of preemptive waitlisting.2 Table 1 - Benefits of preemptive waitlisting and alternative interventions and policies to attenuate disparities in rates of preemptive listing Potential Benefits of Preemptive Referral and Waitlist Placement Alternative Interventions and Policies • Initiate early discussions about living donor transplantation with preemptively listing candidates • Broad utilization of race-agnostic eGFR equations to estimate renal function and preemptive qualification for kidney offers in allocation • Timely evaluation to address pretransplant workup criteria and potential modifiable contraindications • Variable (versus absolute) eGFR criteria for priority eligibility for waitlist placement on the basis of likelihood to progress to ESKD • Potential improvements in timing, preparation, and education for nontransplant modality treatments • Exclude patients with AKI or recovery of kidney function • Improved post-transplant graft and patient survival • Maximize the amount of priority given to preemptive waitlist status (e.g., 2 years) • Engaged and active referral process from general nephrologists and primary care • Initiate priority at the time of "active" status rather than credit given for early inactive status among candidates that are not fully evaluated • Cost savings by avoiding emergency and late start dialysis • Initiate an "opt-out" to transplant referral policy for eligible potential candidates to create more objective processes of care • Improved patient education and autonomy in decision making • Improve the mandate and definition of early education for potential transplant candidates • Longer period of qualification for deceased donors with minimal risk factors for candidates with highest EPTS • Collect data and evaluate transplant center practices for timing and rates of referrals, evaluations, and preemptive listing rates EPTS, expected post-transplant survival. Preemptive transplant referral is particularly beneficial in value-based care models. Payment models that incentive optimal care delivery for patients with CKD, including transplant education and evaluation, have significant potential to reduce health care expenditures and improve health outcomes.3 Medicaid expansion under the affordable care act also has been shown to increase preemptive listing, particularly among minority populations, providing a clear demonstration of the potential effect that payors can have on improving access to transplantation, especially among disadvantaged populations.4 While in an ideal world, even with the elimination of allocation priority for preemptive listing, early referrals to transplantation would continue to increase. However, without the additional benefit of increased allocation priority, the impetus to refer patients with late-stage CKD to transplantation may significantly decline. Preemptive waitlist placement increases the opportunity to receive zero HLA-mismatched transplants (which offers best long-term outcomes), provides younger patients with increased opportunity to access the lowest risk deceased donor kidneys,5 and reduces pretransplant exposure to dialysis which is associated with dramatic improvements in post-transplant allograft survival for patients across different demographic/clinical characteristics. Reduced post-transplant graft survival rates, which would be an inevitable consequence of reduced preemptive transplantation, would lead to higher rates of return transitions to dialysis (a highly morbid and costly process) and increased need for repeat transplantation. Importantly, early referral for transplantation encourages early conversations about the benefits of living donor transplantation, which can be a timely process and have significant value for patients who have yet to identify a willing donor.6 The effect of preemptive transplant referral on patient care not directly related to transplantation is also an important consideration. Although transplant centers may focus on steps in the transplant evaluation process, the rigorous screening and counseling incorporated in the processes such as diet and activity counseling, smoking cessation, and identification of suboptimally managed comorbidities may have important health benefits independent of the transplant episode. Future research evaluating the effect of the transplant evaluation on care processes related to predialysis care is also important and relevant to determine the potential unintended consequences of changes to the preemptive transplant policy. In addition, early decisions regarding patient's eligibility for transplant candidacy at a given center may expedite appropriate care planning for alternative treatment modalities or to allow patients to consider alternative transplant centers in a timely manner. A central theme of the NASEM report was the need for a patient-centered approach for patients with advanced kidney disease. Eliminating incentives for the processes of care of early referral to transplantation would disincentivize optimal care delivery and shared decision making between patients and providers about early treatment options. In fact, this recommendation would seem to tacitly imply that the referral responsibility would be further directed to dialysis providers, which has been a source of inefficiencies and disparities related to transplantation and does not address the more important concern about delayed access to care for the broader transplant-eligible populations across the spectrum of care.7 In addition to risking significantly lower overall access to transplantation, this recommendation may not eliminate disparities given that the implementation would ensure that (1) we would only have living donor preemptive transplantation which is also a source of significant disparities and (2) have no effect on the significant disparities in access to the waiting list among patients receiving maintenance dialysis.8 Given a choice, we would want all eligible patients to be referred, evaluated, waitlisted, and transplanted preemptively if possible. There is broad recognition of this benefit and evidence of improvement given that while overall waitlisting rates for dialysis patients are declining, the proportion of preemptive waitlist placement across all race/ethnicity and age categories is rising. As a result, new models of value-based kidney care incentivize early referral, and the United States has embarked in a national health care policy experiment to improve processes to incentivize optimal predialysis care and expedite transplant referrals with the ESKD treatment choices model—the results of which ought to inform future policy choices. Notably, the NASEM recommendation is in direct conflict with this initiative and would reverse the efforts to shift accountability and shared decision-making opportunities to the general nephrologist from dialysis providers. Thus, rather than simply eliminating policy which is in the broad population's best interest and accept the consequences of substandard health care delivery for all, the critical question is how we can enhance this optimal practice simultaneously while reducing disparities in care. There are numerous alternative interventions and policies that may both improve the rates of preemptive listing and attenuate disparities in care (summarized in Table 1). The use of the new race-agnostic measures of kidney function identifies African American patients as candidates for preemptive listing earlier than prior race-based formula. There may be value in reconsidering the use of variable versus absolute GFR thresholds for preemptive listing given that (1) kidney disease progression rates can vary considerably by disease etiology and (2) patients with severe AKI or dialysis-dependent AKI can have recovery of kidney function (with no policy requirement for pausing accrual of allocation priority with recovery).9 It also may be reasonable to limit the absolute amount of allocation priority that could accrue from preemptive listing (e.g., maximum 2-year benefit). Alternatively, priority based only on time with "active" status on the preemptive waiting list would prioritize patients who are readily available for donor offers. Another potential policy intervention is the use of a proactive "opt-out" of transplant referral model which would mandate referrals for viable patients on the basis of the objective criteria rather than rely on proactive steps by patients with variable levels of health literacy and resources to navigate a complex health care system.10 This is particularly appealing given the similar likelihood by race/ethnicity of waitlist placement given a preemptive referral.11 Racial and ethnic disparities in care are long standing and pervasive among patients with CKD/ESKD, and eliminating these disparities should be a key priority. However, it is unclear whether this specific NASEM recommendation would attenuate disparities, while the detrimental effects may be profound, counter to decades of work to improve access to care, and have broad negative ramifications for the patient population that may benefit from an early transplant referral. This well-intentioned NASEM recommendation for a highly laudable goal to reduce health care disparities is fraught with significant unintended consequences. Rather than a crude policy change that eliminates the preferred treatment in the hope of reducing one potential source of disparities, we should proactively and assertively incentivize and deliver the best health care interventions to all patients with special emphasis on ensuring that populations that have historically not received this care do so prospectively.